PulseDuplicator

The ViVitro Pulse Duplicator system is the world’s most widely cited and most used in-vitro cardiovascular hydrodynamic testing system.

The ViVitro Pulse Duplicator simulates the function of the heart (left or right) by generating pulsatile flow through prosthetic heart valves placed in the Model Heart (Left or Right). Powered by the ViVitro SuperPump, it is composed of the ViVitro Model Heart (Left or Right), SuperPump, Flow Measuring System and ViViTest data acquisition system. The components work together to assess the performance of prosthetic heart valves under simulated cardiac conditions. The ViVitro Pulse Duplicator System is used by the US Food and Drug Administration and is recognised by regulatory bodies worldwide including TÜV, BSI and the Chinese SFDA.

The Pulse Duplicator System assesses the performance of cardiovascular devices and prosthetic heart valves under simulated cardiac conditions. It simulates physiological or other complex flow variations while allowing the user to vary the peripheral resistance and compliance of the system. Pressure ports and flow measuring locations allow for data to be collected from aortic or mitral sites. Transparent viewpoints allow multiple viewing angles of the valve including inflow and outflow.

Combined with the ViVitest software control system, it quickly, easily and reliably collects and analyzes physiological flow and pressure data. The ViVitest software also allows the user to
easily modify and customize waveforms.

The ViVitro Pulse Duplicator System is cited in numerous research studies throughout the world. Visit our Citation Database for the current list of applications and articles.

ViVitest Data Acquisition System (DAS)

ViVitest is part of the ViVitro Data Acquisition System (DAS) family of software products. Combined with the Pulse Duplicator System it collects hydrodynamic testing data to meet ISO 5840 requirements. ViVitest software controls the SuperPump while simultaneously measuring pressure and flow data. It monitors, processes, and reports data such as regurgitant fraction, effective orifice area (EOA), and other valve performance indicators.

A calibration wizard walks new users through the set-up process for quick system preparation for testing. Output files are available in .CSV format for easy analysis in Excel and MatLab.

The ViViTest control system inputs a waveform to the SuperPump while the data acquisition system captures and analyzes physiological pressures and valve flow rates.
Data Acquisition

Flow and pressure readings can be collected and analyzed in real time meeting ISO 5840-2:2015, ISO 5840-3:2013 and FDA requirements

Calibration wizards walk new users through the set up process, facilitating a wide array of data collection options.

Provides output files in versatile formats for easy analysis in Excel and MatLab

Waveform Control

Ability to create and control cardiac waveforms at various physiological states and frequencies, including arrhythmia and wave trains

Waveforms can be easily created with up to 1200 control statements

Product Code: 08530 Data Acquisition System

PN 08311 I/O Module and AP9991 AmPack

Backwards compatible with ViVitro products

.Net 3 Platform

Configured for 64-bit Windows 7 & 10 operating systems

Installer allows for easy updates

Singular program eliminates the need for intrusive third party software

Easy-to-read interface

Pulse Duplicator Data Acquisition System User Manual 20157-A

Request your copy of the Pulse Duplicator Data Acquisition System User Manual 20157-A. Please provide your name, company name and email address. You will receive a download link via the email link provided.

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QCtest Software

Product Code: 26066

ViVitro QCtest checks valve performance against user defined acceptance criteria. It is a turn-key, validated function test software system. The software is easy to use and can be paired with a specific Production Tester Load Assembly on the ViVitro Pulse Duplicator, for quick valve change-outs. This combination is a ready-to use solution for one of the most time-consuming aspects of production to validate.

The QCtest software system was developed as a quality control tool for QC performance testing (function testing) of cardiovascular devices such as heart valves. This production tool provides fast, reliable results at a fraction of the cost of designing and validating an in-house system.
Features:

Pass or fail criteria definable using a secure log-in

Automatically saves pass/fail results along with a report of each test and video

User definable system calibration intervals

Simple user interface

Viscoelastic Impedance Adapter (VIA)

Product Code: VIA7991

The ViVitro Viscoelastic Impedance Adapter (VIA) works in conjunction with the SuperPump to produce more realistic physiological ventricular pressures. It consists of a fixed resistive element and two adjustable compliance chambers to simulate ventricular viscoelastic behavior.

Large Atrium Chamber (Mitral)

Product Code: 21179

The Large Atrium chamber allows devices with an outer diameter of up to 70mm to be tested in the Pulse Duplicator.

Expands the mitral device testing capabilities of the system

Quick-release system allows fast device changes

Accurate flow measurements from flow probe at Atrium inflow

Enhanced visibility using large viewing window for mitral device inflow

Customizable Valve Mounting

Easily added to a ViVitro Pulse Duplicator

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Percutaneous Access Device

Transapical Access Product Code: 18496

Transfemoral Access Product Code: 18497

ViVitro offers two standard methods of deploying percutaneous devices into the Pulse Duplicator system; either Transfemoral or Transapical access (Aortic and Mitral). Additional methods can be customized by ViVitro or third party specialists.

Percutaneous Catheter Access enables the deployment of transcatheter devices in an active Pulse Duplicator while the flow loop is operating under pressure. The Percutaneous Catheter Access is designed to accommodate up to 34 French deployment devices and mounts easily to a ViVitro Model Heart (Left or Right).
Features:

Transapical access can be rotated to access aortic
or mitral valves

Catheter insertion with little to no fluid loss during
pulsatile operation

Replaceable valves

Easy to disassemble and clean

Aortic Conduit Mount (formerly LVOT)

Product Code: 18903

The ViVitro Aortic Conduit Mount (formerly LVOT) can be used to mount a compliant aorta and test percutaneous valves in the ViVitro Model Heart (Left or Right) system. A variety of Aortic Conduit Mount sizes can be custom made to accommodate silicone tubes with relaxed tube IDs of 12-29 mm. A tube may be expandable up to about 50mm OD. The aortic conduit mount accommodates conduit lengths from 44 to 64 mm.

Left Ventricular Assist Device (LVAD) Accessory

Product Code: 25205

The Left Ventricular Assist Device (LVAD) accessory enables testing of LVAD devices with physiological pulsatile flows generated by the ViVitro Pulse Duplicator. It is an optional add-on to the ViVitro Pulse Duplicator. A ventricular cannulation option is also available. Connection points are ½” hose barbs.

The accessory package includes components which provide connection points for the:

The geometry of the aortic root is based on a reasonable simplification of the average
measurements published in manuscripts by Tops (2008) and Buellesfeld (2013) (data procured from MSCT).

Optically clear Acrylic components

28mm I.D. aortic root (other sizes available upon request)

90mm long outflow section

38mm inflow section

PIV setup including laser, lenses, high speed camera, and PIV Load Assembly in a Pulse Duplicator.

PIV Load Assembly Cross Section

Production Tester Quality Control System

Product Codes: 21026

The ViVitro Production Tester Quality Control System provides a simplified system that assesses valve performance criteria for production quality control. It is an add-on to the ViVitro Pulse Duplicator and is intended for Production / QC applications. The Production Tester quickly captures reliable results for a fraction of the cost of designing an in-house system. In conjunction with QCtest software, the Production Tester assesses pressure and flow criteria while recording high speed valve footage via an integrated camera.

Features & Applications

Captures pressure and flow data including:

Transvalvular Pressure

Effective Orifice Area

Regurgitant Fraction

Captures high-speed video

Provides Pass/Fail results

Administrators can set individual operation parameters for technicians:

Operating conditions

User defined Pass/Fail performance assessment

Defined calibration expiry intervals

Test data is tracked by linking result logs to valve model and serial number